Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

Trial Information

Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

OBJECTIVES:

Primary

- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride,
capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

- Analyze the limiting toxicities according to CTC.

- Analyze the toxicity according to CTC.

- Determine the recommended dose.

- Determine the pharmacokinetic dosages of the three drugs.

- Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30
minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib
hydrochloride once daily on days 1-28.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

Completion Date:

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